FDA Inspection
Rnv LLCRnv LLC – FDA Inspection, Jun 17, 2019
Record Details
This FDA Inspection record concerns Rnv LLC, with an inspection on June 17, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · ac018d93-cd1f-4cf0-8cc4-598b818a096e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1092666
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
11- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 111.27(d)(6)Cleaning compounds - adequate, safe
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)(3)Acceptance of drug products
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
- 21 CFR 117.165(b)Sanitation Controls Verif Procedures: Establish Implement
- 21 CFR 111.365(a)Conditions, controls -protect; microorganisms, contamination
- 21 CFR 111.75(c)Specifications met - verify; finished batch
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Other FDA inspections of Rnv LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 31, 2025 | VAI | Florida District Office | Drug Quality Assurance |
| September 5, 2025 | Not classified | Florida District Office | |
| February 25, 2013 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for Rnv LLC
- FDA Inspection 1289892 - 2025-10-31
- FDA Inspection 1281019 - 2025-09-05
- FDA Inspection 819846 - 2013-02-25
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